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Lorus announces initiation of IND-enabling toxicology studies for its lead small molecule drug, LOR-253

- Toxicology studies in preparation for an investigational new drug
application to the US FDA -
TORONTO, March 25 /CNW/ - Lorus Therapeutics Inc. ('Lorus'), a
biopharmaceutical company specializing in the research and development of
pharmaceutical products and technologies for the management of cancer, today
announced the start of GLP toxicology studies for its lead anticancer small
molecule drug LOR-253.
The toxicology studies, which are currently underway, are designed to
support the filing of an Investigational New Drug (IND) application with the
U.S. FDA for LOR-253 to initiate a Phase I clinical study in cancer
indications. Lorus intends to submit an IND for LOR-253 during the
fourth quarter of 2008, following successful completion of the toxicology
program.
LOR-253 (formerly known as LT-253) is a proprietary small molecule
compound discovered at Lorus and optimized for its anticancer properties. In
preclinical studies, LOR-253 has shown selective and potent antitumor activity
in a variety of human cancers, including colon cancer and non-small cell lung
cancer, and has an excellent therapeutic window due to its low toxicity. The
mode of action of LOR-253 involves the downregulation of cyclin D1, an
important regulator of cell cycle progression and cell proliferation.
Alterations in the cyclin D1 regulatory pathway have been linked to the
development of cancer.
"LOR-253 is the first compound from our small molecule program to advance
to GLP toxicology studies. Moving LOR-253 forward is consistent with Lorus'
focus on development of novel drugs from a broad range of technologies. From a
drug development perspective, this represents a significant milestone towards
filing an IND application for clinical investigation. We are very excited
about the progress we have made in the development of this unique class of
anticancer drug discovered at Lorus as represented by LOR-253," said Dr.
Aiping Young, President and CEO of Lorus.
About Lorus
Lorus is a biopharmaceutical company focused on the research and
development of novel therapeutics in cancer. Lorus' goal is to capitalize on
its research, preclinical, clinical and regulatory expertise by developing new
drug candidates that can be used, either alone, or in combination with other
drugs, to successfully manage cancer. Through its own discovery efforts and an
acquisition and in-licensing program, Lorus is building a portfolio of
promising anticancer drugs. Lorus has completed one Phase II and one Phase III
clinical trial. Lorus Therapeutics Inc. is listed on the Toronto Stock
Exchange under the symbol LOR, and on the American Stock Exchange under the
symbol LRP.
Forward looking statements
This press release contains forward-looking statements within the meaning
of Canadian and U.S. securities laws. Such statements include, but are not
limited to, statements relating to: financings and corporate reorganizations,
the establishment of corporate alliances, the Company's plans, objectives,
expectations and intentions and other statements including words such as
"continue", "expect", "intend", "will", "should", "would", "may", and other
similar expressions. Such statements reflect our current views with respect to
future events and are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while considered
reasonable by us are inherently subject to significant business, economic,
competitive, political and social uncertainties and contingencies. Many
factors could cause our actual results, performance, achievements or the
transactions described in this press release to be materially different from
any future results, performance, achievements or transactions described in
this press release, if at all, that may be expressed or implied by such
forward-looking statements, including, among others: the progress of
negotiations; our ability to obtain regulatory, security holder and other
approvals; our ability to obtain the capital required for research and
operations; the inherent risks in early stage drug development including
demonstrating efficacy; development time/cost and the regulatory approval
process; the progress of our clinical trials; our ability to find and enter
into agreements with potential partners; our ability to attract and retain key
personnel; changing market conditions; and other risks detailed from
time-to-time in our ongoing quarterly filings, annual information forms,
annual reports and annual filings with Canadian securities regulators and the
United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should
the assumptions set out in the section entitled "Risk Factors" in our filings
with Canadian securities regulators and the United States Securities and
Exchange Commission underlying those forward-looking statements prove
incorrect, actual results may vary materially from those described herein.
These forward-looking statements are made as of the date of this press release
and we do not intend, and do not assume any obligation, to update these
forward-looking statements, except as required by law. We cannot assure you
that such statements will prove to be accurate as actual results and future
events could differ materially from those anticipated in such statements.
Investors are cautioned that forward-looking statements are not guarantees of
future performance and accordingly investors are cautioned not to put undue
reliance on forward-looking statements due to the inherent uncertainty
therein.
Lorus Therapeutics' recent press releases are available through the
Company's website at www.lorusthera.com. For Lorus' regulatory filings on
SEDAR, please go to Sedar.com. For SEDAR filings prior to July 10, 2007 you
will find these under the company profile for Global Summit Real Estate Inc.
%SEDAR: 00025614E %CIK: 0000882361